I USO05321109A

United States Patent [19] [11] Patent Number: 5,321,109

Bosse et al. [45] Date of Patent: Jun. 14, 1994
[54] UNIFORMLY EXPANDED PI'FE FILM
FOREIGN PATENT DOCUMENTS
[75] Inventors: Charles F. Bosse; Rajagopal R. 2825210 6/1978 Fed. Rep. of Germany .
Kowligi, both of Tempe, Ariz. 63247-02l-A 4/ 1987 Japan .
l329-99l-A 3/1985 U.S.S.R. .
[73] Assignee: Impra, Inc., Tempe, Ariz. OTHER PUBLICATIONS
[21] Appl. No.: 977,562 T. M. Long Co. Inc., undated product catalog of labo
ratory Instruments, pp. 1-36, “Film Stretcher”.
[22] Filed: Nov. 17, 1992 Primary Examiner-Leo B. Tentoni
' Attorney, Agent, or Firm-Cahill, Sutton & Thomas
[51] Im. c1.s ............................ .'..' ........... .. C08F 114/26
[52] US. Cl. ........................ .. 526/255; 428/910 [57] xasrnxcr
[58] Field of Search .............. .. 264/291, 127; 428/910; A uniformly expanded PTFE ?lm is provided by ex
526/255 truding a PTFE ?lm and gripping the unexpanded ?lm
about its periphery with a number of symmetrically
[56] References Cited disposed gripping members each equidistant from the
U.S. PATENT DOCUMENTS center of the ?lm. The extruded PTFE ?lm is heated to
2,759,217 8/1956 Peterson ............................ .. 264/291
a temperature in the range of 200-300 degrees Centi
2,873,474 2/1959 Shields et a1. . . . . . , . . . .. 425/383
grade before expanding the extruded PTFE ?lm. The
2,912,716 11/1959 Frownfelter et a1. ........ .. 26/1 gripping members are simultaneously rotated through
2,933,759 4/1960 Startzell ............ .. . 425/403 an are away from the center of the film, as by pivotally
3,962,153 6/1976 Gore .._ ....... .. . 264/127 securing each gripping member to the end of an associ
4,085,175 4/1978 Keuchel .... .. 264/51 ated expansion arm and rotating the end of each expan
4,187,390 2/1980 Gore ......... .. . 174/102 sion arm away from the center of the ?lm while main
4,304,010 12/1981 Mano . . .. .. . .. .. ,. . . . . .. 3/1.4
taining the gripping members equidistant from the cen
4,331,624 5/1982 Yazawa et a1. . 264/160
ter of the ?lm. The expansion arms are uniformly r0
4,374,690 2/1983 Canterino et a1. .. 156/229
4,685,230 8/1987 Mason, III ........ .. 38/1025
tated by a geared shaft powered by a drive mechanism
4,830,062 5/1989 Yamamoto et al. . 138/177 that extends through the wall of an oven for coupling to
4,877,661 10/1989 House et al. 428/34.9 an external motor.
4,966,807 10/1990 Harvey et a1. .. 428/220
5,167,987 12/1992 Yu ..................................... .. 264/291 1 Claim, 6 Drawing Sheets
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US. Patent June 14, 1994 Sheet 6 of 6 5,321,109
 1 5,321,109 2
tear resistance. For example, if a PTFE ?lm is used as a
UNIFORMLY EXPANDED PTFE FILM vessel repair patch, the physician sometimes cuts the
patch from a larger ?lm to provide a patch of custom
BACKGROUND OF THE INVENTION ized dimensions, and the manufacturer does not know,
1. Field of the Invention and can not predict, which way the physician will ori
The present invention relates generally to apparatus ent the ?lm when trimming the ?nal patch. Conse
for stretching expandable polymer ?lms such as PTFE quently, it would be desirable to produce PTFE ?lms
?lms, and more particularly, to an apparatus and that are expanded in such a way that their characteris
method for stretching and expanding polymer ?lms in tics, such as tensile strength and suture tear resistance,
multiple directions to more uniformly expand such are more uniform and not as dependent upon the partic
?lms. ular axis or orientation along which the stress forces are
2. Description of the Relevant Art applied.
Polytetrafluoroethylene (PTFE) is an expandable Accordingly, it is an object of the present invention
polymer which ?nds many uses in medicine and indus to provide a simple and inexpensive apparatus to stretch
try. As PTFE is stretched during expansion, it forms a 15 and expand ?lms of PTFE and like materials in a multi
porous microstructure of nodes and ?brils. The direc tude of directions outwardly from the center of the
tion in which the PTFE is stretched may affect the original ?lm to provide a multi-directional expansion of
tensile strength of the resulting tube or ?lm as measured the ?lm. I
in different directions relative to the direction in which It is a another object of the present invention to pro
the material was expanded. - 20
vide such an apparatus which conveniently allows the
It is known to stretch PTFE material along a single expanded ?lm to be sintered following expansion.
expansion axis, or uniaxially. It is also known to stretch It is still another object of the present invention to
PTFE along two different axes. For example, U.S. Pat.. provide a method of uniformly expanding PTFE ?lms
No. 4,187,390 to Gore discloses the formation of ex
in a multitude of directions to provide a multi-direc
panded tubes and ?lms made of PTFE. In one example 25
described in such patent, a PTFE ?lm measuring 4" by
tional expansion of the ?lm.
4" was stretched to a 16" by 16" ?lm by stretching the It is a still further object of the present invention to
?lm biaxially. The patent speci?cation states that biaxial provide PTFE ?lms exhibiting substantially uniform
stretching was performed on a “pantograph”; in de-' . tensile strength and suture tear resistance irrespective of
scribing the use of such pantograph, the patent speci? 30 the orientation of the ?lm relative to the stress forces
cation states that the “4"><4" ?lm was gripped on each being applied.
side by 13 actuated clamps, which moved apart uni Still another object of the present invention is to be
formly on a scissor mechanism.” ‘ able to perform the expansion of such ?lm in a sealed
In addition, US. Pat. No. 4,304,010 to Mano de oven of relatively small size to closely control the tem
scribes a prosthetic vascular graft made of PTFE ex 35 perature of the ?lm during the expansion process while
panded both longitudinally and radially; Mano de conveniently maintaining control over the rate at which
scribes this process as biaxial stretching of the PTFE the ?lm is expanded. Yet another object of the present
tube. invention is to provide apparatus adapted to separately
PTFE can be stretched to many times its original expand a plurality of PTFE ?lms, which expanded ?lms
dimensions. Prior to expansion, the extruded PTFE ?lm 40 can then be simultaneously sintered in a sintering oven.
is typically heated to approximately within the range of A further object of the present invention is to provide
225-300 degrees Centigrade. Upon reaching such tem an expansion apparatus which is relatively inexpensive
perature, the ?lm is expanded by stretching to a desired to produce and use, yet which uniformly expands a
dimension. Following expansion, the PTFE ?lm is polymer ?lm.
heated to a higher sintering temperature of approxi 45 A still further object of the present invention is to
mately 375 degrees Centigrade or higher to lock the provide such an expansion apparatus wherein the ex
crystalline structure to its expanded dimensions. During panded ?lm can be easily and quickly locked in its ex
this sintering step, the expanded ?lm must be held to its panded condition and removed from the expansion
expanded dimensions, or the ?lm will contract partially apparatus prior to sintering.
back toward its pre-expanded shape. 50 These and other objects of the invention will become
When PTFE ?lms are used for medical/surgical ap more apparent to those skilled in the art as the descrip
plications, manufacturers and users of PTFE products tion of the present invention proceeds.
are often concerned with both tensile strength and su
ture tear resistance. Tensile strength is a measure of SUMMARY OF THE INVENTION
how hard the PTFE material can be stretched along a 55 Brie?y described, and in accordance with a preferred
particular axis before the material breaks. Suture tear embodiment thereof, the present invention provides an
resistance is a measure of how much force can be ap apparatus for uniformly expanding a polymer ?lm in
plied to a suture that has been sewn through the PTFE multiple directions outwardly from the center of the
material before such force tears a hole in the PTFE ?lm, and includes a number N of symmetrically-dis
material. Both tensile strength and suture tear resistance 60 posed expansion arms, each of the expansion arms being
can be sensitive to the axis along which expansion was pivotally mounted for pivoting one end of each expan
performed during processing of the PTFE material. sion arm toward or away from the center of the ?lm to
When PTFE materials are used as implantable pros be expanded. The apparatus includes a corresponding
thetic devices, such as vessel repair patches or grafts, number N of ?lm gripping members each adapted to
the surgeon may place the patch or graft in a variety of 65 releasably engage a peripheral portion of the ?lm to be
different orientations, and there is no guarantee that expanded. Each ?lm gripping member is pivotally se
sutures sewn through such PTFE material will neces cured to an end of an associated expansion arm for
sarily be oriented in the direction of maximum suture movement toward or away from the center of the ?lm,
 5,321,109
3 4
and the ?lm gripping members are symmetrically dis Another aspect of the present invention is a process
posed about a central axis coincident with the center of for uniformly expanding a polymer ?lm in multiple
the polymer ?lm. directions, wherein the periphery of the ?lm is secured
The apparatus includes a pivot drive mechanism for to a number of symmetrically-disposed ?lm gripping
simultaneously pivoting the group of expansion arms in members each being equidistant from the center of the
a direction for uniformly moving the ends of the expan ?lm. Each of the ?lm gripping members is simulta
sion arms to which the gripping members are secured neously rotated through an are away from the center of
away from the center of the ?lm. Each of the ?lm grip the ?lm to stretch and expand the ?lm while maintain
ping members pivots to face the center of the ?lm as its ing the ?lm gripping members equidistant from the
associated expansion arm pivots away from the center center of the ?lm. As the ?lm gripping members are
of the ?lm to continuously maintain the stretching force rotated away from the center of the ?lm, each ?lm
applied by each ?lm gripping member along a radial gripping member is pivoted to continuously face the
path extending outwardly from the center of the ?lm. center of the ?lm in order to maintain the pulling force
Preferably, the radial path along which each ?lm grip exerted by each ?lm gripping member radial relative to
ping member applies its stretching force rotates as its the center of the ?lm. In carrying out such process, each
associated expansion arm pivots outwardly away from ?lm gripping member can be pivotally secured to an
the center of the ?lm. The pivot drive mechanism main associated expansion member for ensuring that the pull
tains the ?lm gripping members equidistant from the ing force exerted by the ?lm gripping member is di
center of the ?lm during the expansion of the ?lm. rected radially relative to the center of the ?lm. The
In the preferred embodiment of the above-summa 20 process preferably includes the step of trimming the
rized apparatus, each expansion arm is pivotally secured periphery of the ?lm to correspond with the pattern of
to a base proximate the end thereof opposite the grip ?lm gripping members before such ?lm gripping mem
ping member. The pivot drive mechanism includes a bers are expanded. In the preferred embodiment of the
rotatable drive ring to which each of the expansion process, the rate at which each ?lm gripping member
arms is coupled between the opposing ends thereof. 25 moves away from the center of the ?lm continuously
Each expansion arm has a slot formed therein between increases as each ?lm gripping member is rotated fur
the opposing ends thereof; the drive n'ng includes a ther away from the center of the ?lm.
number N of engagement pins symmetricallydisposed In practicing such process, the polymer ?lm may
about the ring, and each of the engagement pins engages advantageously consist of extruded PTFE. The process
a slot of one of the expansion arms for sliding engage preferably includes the step of heating the extruded
ment therewith. As the drive ring is rotated in a ?rst PTFE ?lm to a temperature in the range of 200-300
direction, each of the expansion arms is pivoted away degrees Centigrade before expanding the ?lm. The
from the center of the ?lm to simultaneously move the extruded PTFE ?lm may initially include a lubricant,
gripping members through an arc outwardly away from and the process preferably includes the steps of folding
the center of the ?lm. " the extruded ?lm upon itself, rolling the folded PTFE
35
The drive ring is preferably mounted to a geared ?lm between a pair of rollers, and drying the lubricant
shaft concentric with the drive ring, and a power source from the rolled PTFE ?lm before securing the ?lm to
engages the geared shaft for rotating said geared shaft in the ?lm gripping members
order to rotate the drive ring. In order to permit the The process of the present invention also preferably
polymer ?lm to be maintained at an elevated tempera 40 includes the step of locking the expanded ?lm in its
ture during expansion, the apparatus preferably includes expanded dimensions, and heating the locked ?lm at a
an oven having insulated walls, and one of the insulated’ temperature above 350 degrees Centigrade to sinter the
walls includes a rotatable drive member extending PTFE ?lm. This locking step includes the step of apply
therethrough. The rotatable drive member has a ?rst ing a clamping mechanism to opposing faces of the
end accessible from outside the oven for coupling to a 45 expanded ?lm before releasing the expanded ?lm from
drive motor external from the oven; the rotatable drive the ?lm gripping members.
member also has an opposing second end accessible
from the inside wall of the oven for coupling to the BRIEF DESCRIPTION OF THE DRAWINGS -
geared shaft to rotate the drive ring. The external drive FIG. 1 is a perspective view of an eight-arm radial
motor rotates the geared shaft at a substantially constant 50 expansion apparatus for multi-directional expansion of a
speed, whereby the rate at which the gripping members ' PTFE ?lm, and illustrating the radial expansion arms in
move away from the center of the ?lm continuously their initial starting position.
increases the as the gripping members move further FIG. 2 is a top view of the expansion apparatus
away from the center of the ?lm. shown in FIG. 1.
Ideally, the apparatus includes a clamping device for 55 FIG. 3 is a top view of the expansion apparatus
clamping the ?lm following expansion, while allowing shown in FIG. 1 but showing the expansion arms being
the ?lm to be removed from the gripping members. The rotated'toward their ?nal expanded positions.
clamping device contacts the ?lm internal from the FIG. 4 is a side view of the expansion apparatus
peripheral edges of the ?lm for allowing the peripheral shown in FIG. 1 and illustrating the drive mechanism
edges of the film to be released from the ?lm gripping 60 for uniformly rotating and expanding the expansion
members. The clamping device retains the ?lm in its arms of such apparatus.
expanded condition for sintering at an elevated temper FIG. 5 is a close-up view of the ?lm clamping mem
ature. In one preferred form, the clamping device in bers of the expansion apparatus of FIG. 1 prior to ex
cludes ?rst and second rings applied to opposing faces pansion, and further illustrating a grid drawn upon the
of the expanded ?lm. The ?rst and second clamp rings 65 PTFE ?lm to be stretched.
are releasably fastened to each other to lock the ?lm in FIG. 6 is a close up view of the ?lm shown in FIG. 5
its expanded state before the ?lm is released from the after the radial expansion arms have been rotated to
gripping members. expand the ?lm.
 5,321,109
5 6
FIG. 7A is a close-up view of the ?lm clamping mem a common base plate 46. Similarly, seven additional
bers of an alternate embodiment of the present inven pedestals are secured to and spaced about base plate 46
tion using only four radial expansion arms. equiangularly and equidistant from the center of base
FIG. 7B is a close up view of the ?lm shown in FIG. plate 46 for pivotally supporting the other seven expan
7A after the radial expansion arms have been rotated to sion arms 22-34.
expand the ?lm. Pivot pin 42 has a smooth upper shaft which passes
FIG. 8 is a bottom view of the expansion apparatus of through a similarly-sized aperture 48 in the ?rst end 38
FIG. 1 showing the drive gear for uniformly rotating of expansion arm 36; the ?rst end of expansion arm 36 is
the expansion arms. free to rotate about the smooth upper shaft of pivot pin
FIG. 9 is a schematic drawing of one ?lm clamping 42. The lower end (not shown) of pivot pin 42 is of
member and its associated radial expansion arm, and reduced diameter and slips into a bore formed in the
illustrating the manner in which the expansion force is upper end of pedestal 44 for releasably securing ?rst end
maintained in a radial direction from the center of the 38 of expansion arm 36 to pedestal 44. The upper end of
?lm. ' ' pivot pin 42 includes an enlarged knurled knob 50 to
FIG. 10 is a flow chart summarizing the processing allow a user to conveniently secure or release expansion
steps used in the preferred embodiment of the present arm 36 to or from pedestal 44, as desired.
invention for making expanded PTFE ?lms having Shown in the center of FIG. 1 is a polymer ?lm 52
substantially uniform tensile strength and suture tear formed of extruded PTFE. The extruded ?lm is initially
resistance characteristics. , trimmed to an eight-sided octagonal shape. An octagon
FIG. 11 is a step-by-step illustration of a calendering 20 ally-shaped steel template 53 is shown in FIG. 12 for
and folding process for preparing a PTFE ?lm for ra such purpose. A plurality of eight ?lm gripping mem
dial expansion using the present invention. bers, designated by reference numerals 54, 56, 58, 60, 62,
FIG. 12 illustrates an octagonal-shaped template for 64, 66, and 68 are symmetrically disposed about the
trimming an unexpanded PTFE ?lm to prepare for central axis of the apparatus coincident with the center
expansion using the expansion apparatus of ‘FIG. 1. 25 of PTFE ?lm 52. Referring brie?y to FIG. 3, the center
FIG. 13 is a perspective view of an expanded PTFE of the ?lm, and the central axis of the apparatus, are
?lm in conjunction with upper and lower retainer rings designated by intersection point 51. Film gripping mem
used to maintain the expanded‘ dimensions of the bers 54-68 are pivotally secured to the second, or inner,
stretched ?lm prior to sintering. end of expansion arms 22—36, respectively. Each of the
FIG. 14 is a side view of the expanded PTFE ?lm expansion arms 22-36 is of equal length, and each of the
retained by the upper and lower retainer rings shown in ?lm gripping members is equidistant from the central
FIG. 13. ' axis of the apparatus, and equidistant from the center of
FIG. 15 is a perspective view of the stretched ?lm the PTFE ?lm. ‘
maintained in its expanded condition by the retainer Each of ?lm gripping members 54-68 is adapted to
rings and suspended by a hook for placement in a sinter 35 releasably engage a peripheral portion of PTFE ?lm 52.
ing oven. Referring to FIGS. 2 and 4, ?lm gripping member 54
FIG. 16. is a partial perspective view of an expansion includes an upper clamp bar 70 and a lower clamp bar
oven wall modi?ed to receive a rotatable drive member 72. Similarly, ?lm gripping member 66 includes an
for allowing the PTFE ?lm to be expanded in an oven upper clamp bar 74 and a lower clamp bar 76. Lower
using the apparatus of FIG. 1 at a controlled rate and clamp bar 72 has an inwardly extending ridge, while
temperature. ' upper clamp bar 70 has a mating downwardly depend
Yet another aspect of the present invention is the ing tooth; the tooth and mating ridge ?rmly grasp the
uniformly expanded PTFE ?lm which results from PTFE ?lm therebetween. Releasable hex head screws
practicing the above-described process. 78 secure upper clamp bar 74 to lower clamp bar 72
45 after the peripheral portion of the PTFE ?lm is engaged
DETAILED DESCRIPTION OF THE therebetween.
PREFERRED EMBODIMENT
As described above, each ?lm gripping member is
A preferred form of apparatus for uniformly expand pivotally secured to the inner end of its associated ex
ing a PTFE polymer ?lm in a multitude of directions in pansion arm. For example, as shown in FIG. 4, lower
accordance with the teachings of the present invention 50 clamp bar 72 of ?lm gripping member 54 is pivotally
is designated generally in FIG. 1 by reference numeral secured to the inner end of expansion arm 22 by a hex
20. Expansion apparatus 20 includes a plurality of eight head bolt 80. Bolt 80 has a smooth upper bore for en
expansion arms designated by reference numerals 22, gaging a correspondingly sized aperture (not shown) in
24, 26, 28, 30, 32, 34, and 36. Expansion arms 22-36 are lower clamp bar 72 of ?lm gripping member 54. Ac
symmetrically-disposed about the center of the appara 55 cordingly, ?lm gripping member 54 can freely pivot
tus. As shown in FIG. 1, each expansion arm initially about bolt 80. The lowermost end of bolt 80 is threaded
extends radially toward the center of the apparatus, and to engage a threaded hole formed in the inner end of
each expansion arm is offset at an angle of 45 degrees expansion arm 22.
from the leading and trailing expansion arms. Each As described above, apparatus 20 includes a pivot
expansion arm has ?rst and second opposing ends. For 60 drive mechanism for simultaneously pivoting the group
example, as shown in FIG. 1, expansion arm 36 has a of expansion arms 22-36 in a direction for uniformly
?rst outer end 38 and a second opposing inner end 40. moving the inner ends of such expansion arms, along
The ?rst, or outer, end of each expansion arm is piv with their associated gripping members, away from the
otally mounted for pivoting the opposing second inner center of the ?lm. This pivot drive mechanism prefera
end of the expansion arm toward or away from the 65 bly includes a rotatable pivot drive ring 82 shown in
center of the apparatus. For example, in FIG. 1, the ?rst FIGS. 1, 2 and 4. Each of expansion arms 22-36 is slid
end 38 of expansion arm 36 is pivotally secured by a ingly coupled to rotatable ring 82 between the opposing
pivot pin 42 to a pedestal 44 which is in turn secured to outer and inner ends thereof. For example, expansion
 5,321,109
7 8
arm 36 includes a longitudinally extending slot 84 ping members. The apparatus for causing drive ring 82
which extends from approximately the midpoint of to rotate will now be described with reference to FIGS.
expansion arm 36 to a point proximate inner end “40 1-4. Drive ring 82 is secured to a lower ring 90 by a
thereof. Mechanical coupling between ring 82 and ex series of spaced bolts, like those designated 92 in FIG. 1.
pansion arm 36 is effected by a hex head engagement As shown in FIG. 4, spacer washers like that designated
stud 86 which slides within slot 84. The lowermost end 94 inserted between ring 82 and lower ring 90 cause
of stud 86 is threaded to engage a threaded hole (not drive ring 82 to be spaced slightly above and out of
shown) formed in ring 82. The uppermost portion of contact with lower ring 90. Limit pins 96 prevent ex
mud 86 is smooth for sliding engagement along slot 84. pansion arms 22—36 from being pivoted so far as to
Each of the other expansion arms is coupled to ring 82 contact bolts 92.
vin a similar fashion by similar engagement studs which As shown in FIG. 4, lower ring 90 is secured to a
are disposed equiangularly about the upper surface of support plate 98 by attachment bolts 100. Support plate
ring 82. With reference to FIG. 2, those skilled in the art 98 is, in turn, supported by a vertically mounted support
will appreciate that, as ring 82 is rotated counterclock shaft 102 journaled in bushing 104. Support shaft 102 is
wise, each expansion arm is forced to rotate in a clock concentric with drive ring 82 and concentric with the
wise direction about the pivot point at its outer end, central axis of the expansion apparatus. Bushing 104 is
thereby causing the inner end of each expansion arm, contained within cylindrical support 106 which is se
and hence each gripping member, to simultaneously cured over a central hole in base plate 46 by bolts 108.
move through a circular are away from the center of A horizontal circular gear 110 is secured over support
the apparatus, and away from the center of the ?lm, as 20 shaft 102 and engages a worm gear 112 shown best in
generally indicated by FIG. 3. Likewise, subsequent FIG. 8. Worm gear 112 is formed upon horizontal drive
rotation of ring 82 in the clockwise direction tends to shaft 114 which is rotatably supported on either side of
force the gripping members to return back to their ini worm gear 112 by bushing blocks 116 and 118, each of
tial pre-expanded position shown in FIG. 2. which is secured to base plate 146. Rotation of drive
As shown best in FIGS. 3 and 9, each ?lm gripping 25 shaft 114 is coupled by worm gear 112 to toothed gear
member moves outwardly from the center 51 of the 110, which in turn causes vertical shaft 102, lower ring
PTFE ?lm along an arcuate, non-radial path in the 90, and drive‘ ring 82 all to rotate in response.
particular embodiment shown. This arcuate path is As noted above, expansion of PTFE ?lms is typically
shown by the arrow designated 87 in FIG. 9. In FIG. 3, carried out at temperatures well above room tempera
the initial position of, expansion arm 36 and associated 30 ture. While it is possible to heat such ?lms with hot air
gripping member 68 are shown in dashed outline by the guns, better temperature control can be achieved if the
components labelled 36' and 68', respectively. As ring expansion can be performed in an insulated oven with
82 rotates counterclockwise, as indicated by arrows 88, insulated walls and a controllable heat source. Accord
expansion arm 36 and gripping member 68 move to the ingly, it is desirable to place expansion apparatus 20 in
solid-line positions shown in FIG. 3; note that pin 86 has an oven with insulated walls before the temperature of
begun to advance through slot 84 of expansion arm 36. the ?lm is raised to the desired temperature for expan
Continued rotation of ring 82 causes expansion arm 36 sion. Within FIG. 3, expansion apparatus 20 is shown
and gripping member 68 to advance to the dashed line within an insulated oven including side walls 118 and
positions indicated by 36" and 68", respectively. Thus, 120 and rear wall 122. The oven may also include an
while gripping member 68 is initially pulling on the ?lm 40 insulated door (not shown), as well as a ?oor 124 (see
along a radius passing through pivot pin 42, continued FIG. 16) and a ceiling (not shown). A power coupler
rotation of drive ring 82 results in the rotation‘of theextends through rear wall 122 of the oven. As shown in
pulling force exerted by gripping member 68 toward a FIG. 16, the rotatable power coupler includes a shaft
radius displaced from the initial radial path by an angle
126 having a square recess 127 formed in the end of the
of approximately 45 degrees. 45 shaft internal to the oven. The portion of power cou
As further demonstrated in FIGS. 3 and 9, gripping pling shaft external to the oven is coupled to an external
member 68 always faces the center of the ?lm through electrical motor 128, the speed and duration of which
out the arcuate movement of expansion arm 36. Grip can be programmed.
ping member 68 is pivotally secured to the inner end of As shown in FIGS. 1 and 8, the end 130 of horizontal
expansion arm 36, and this pivotal connection continu 50 drive shaft 114 that protrudes from bushing block 116 is
ously maintains the stretching force applied by each splined in a square shape for being removably received
?lm gripping member along a radial path extending within the squared recess 127 of power coupling shaft
outward from the center of the ?lm. Referring to FIG. 126 shown in FIG. 16. Accordingly, in using the present
9, the original radial path is designated R1. As ring 82 apparatus, the unexpanded ?lm can be secured to the
rotates, gripping member 68 moves to exert a radial 55 group of gripping members, and the loaded expansion
stretching force along the radial path designated R2. ‘ apparatus can then be placed into the oven, being care
Further rotation of ring 82 moves gripping member 68 ful to engage splined end 130 of driveshaft 114 into
further away from center 51 of the PTFE ?lm, so that square recess 127, before closing the oven door and
the stretching force is exerted along the radial path raising the temperature inside the oven. After the de
designated R3. The angular rotation of such radial path, 60 sired temperature is achieved, motor 128 i operated to
from R1 through R; to R3, as the gripping member controllably rotate drive ring 82, thereby expanding the
moves outwardly is believed to contribute to the uni ?lm. Motor 128 can be operated at a constant speed for
form expansion of the ?lm. Each of the other gripping better control; if motor 128 is operated at constant
members undergoes the same motion, whereby each of speed, driveshafts 114 and 102 also rotate at a substan
the ?lm gripping members is maintained equidistant 65 tially constant speed. However, the radial pull rate at
from the center 51 of the ?lm. which the gripping members move away from the cen
As described above, circular drive ring 82 is rotated ter of the ?lm, if expressed in terms of inches per sec
to simultaneously move the expansion arms and grip ond, continuously increases as the as the gripping mem
 5,321,109
9 10
bers move further away from the center of the ?lm, as bar 74 from lower clamp bar 72 in each ?lm gripping
is apparent from the schematic drawing of FIG. 9. This member, in preparation for the next ?lm expansion
increase in radial rate of stretching is desirable as expan cycle. This procedure avoids the need to expose the
sion rates are often speci?ed inpercentage expansion expansion arms and drive ring 82 to the higher tempera
over unit time, rather than in inches per unit time. tures of the sintering oven.
Once the ?lm is expanded in the manner explained Another aspect of the present invention relates to a
above, the expanded ?lm must be sintered. This sinter process for uniformly expanding a polymer ?lm, such as
ing operation could be performed in the same oven used PTFE, in multiple directions. In carrying out the pre
for the expansion, if desired. However, it may be pre ferred process using PTFE as the polymer, the PTFE
ferred to ?rst remove the expanded ?lm from the expan resin is mixed with a lubricant to form a paste and is
sion oven, and to sinter the ?lm in a separate oven. This extruded into a thin ?lm using known processing. US.
latter method provides the advantage of being able to Pat. No. 4,187,390 to Gore discloses one method of
‘ use the ?rst oven exclusively for expansion, and being extruding a thin PTFE ?lm, and the speci?cation of
able to expand a new ?lm without waiting for the ?rst such patent is hereby incorporated by reference. This
expanded ?lm to be sintered. In addition, several ex initial step of extruding the PTFE ?lm is shown as step
panded ?lms can all be sintered in the second oven at 146 in the ?owchart of FIG. 10.
the same time,_thereby minimizing the number of sinter To enhance the uniformity of the extruded ?lm, a
ing operations that need to be performed. calendering process is preferably used prior to expan
One method of locking the ?lm in its expanded condi sion of the ?lm. This calendering process is signi?ed by
tion prior to sintering while removing the ?lm from the 20 step 149 in FIG. 10 and is demonstrated in FIG. 11. The
expansion apparatus is to apply one or more lock bars calendering process is performed before drying the
(not shown) to lock the expansion arms in place relative lubricant from the extruded PTFE ?lm. First, the ini
to drive ring 82. The lock bars have holes drilled in eachtially extruded PTFE ?lm 147 is rolled between a pair
thereof. The hole at one end of the lock bar ?ts over one of smooth rollers 148 and 150, thinning the extruded
of the pins 96 extending upwardly from drive ring 82. 25 ?lm from an initial thickness of approximately 1.3 mm.
The hole at the opposite end of the lock bar is ?tted to 0.9 mm. The rolled ?lm may then be rotated 90 de
over one of the pins 132 (see FIG. 1) extending up grees and sent back through the rollers, if desired. The
wardly from each of the expansion arms. After one or rolled film is then folded on itself along the direction in
more of the lock bars are applied, drive ring '82 and which it was initially sent through rollers 148 and 150,
expansion arms 22-36 can be removed from the remain 30 as indicated by arrow 152 in FIG. 11, thereby increasing
der of the expansion apparatus, as by unfastening pivot the thickness of the folded ?lm. The folded ?lm is then
pins 42 and drive ring bolts 92. The locked expansion sent back through rollers 148 and 150, with the fold line
arms and drive ring can then be placed in the sintering extending in the direction of travel through the rollers,
oven, thereby avoiding the need to expose the bushings as indicated by arrow 154 in FIG. 11, again thinning the
and/or bearings of the expansion apparatus to the high 35 rolled ?lm. The resulting ?lm is then folded over itself,
temperatures of the sintering oven. > this time with the fold line extending perpendicular to
However, a preferred method of locking the ex the direction of travel through the rollers, as indicated
panded ?lm in its expanded condition for removal from by arrow 156 in FIG. 11. Finally, the ?lm 147 is run
the expansion apparatus prior to sintering is shown in through rollers 148 and 150 again, this time with the
FIGS. 13 and 14. Within FIG. 13, the expanded ?lm 52 40 fold line oriented perpendicular to the direction of
is shown still grasped by expanded gripping members travel through the rollers. The lubricant is then dried
22-36. A ?rst clamping ring 134 is supported above from ?lm 147 prior to expansion of the ?lm by heating
expanded ?lm 52, and a second clamping ring 136 is the ?lm to approximately 40 degrees Centigrade for
placed below ?lm 152, as shown in FIG. 13. First approximately one hour. The above-described calen
clamping ring 134 has a series of four smooth bore holes 45 den'ng process is carried out at room temperature and
138, and second clamping ring 136 has a second series of provides a starting ?lm of more uniform thickness,
four threaded holes 140. The two clamping rings 134 much like rolling pie dough with a rolling pin. The
and 136 ar ®moved toward each other, while aligning thickness of the resulting PTFE ?lm 147 varies in ac
the two series of holes 138 and 140; the rings are held cordance with the number of calendering operations,
against each other while fastening bolts 142 are inserted but typically ranges between approximately 0.9 mm.
through holes 138, through ?lm 52, and into threaded and 0.3 mm. thick. For example, if the PTFE ?lm will
holes 140 to positively secure the rings together, with be used to form vascular patches, a calendered thickness
the expanded ?lm clamped therebetween. of 0.6 mm. to 0.8 mm. is preferably produced to provide
The diameters of clamping rings 134 and 136 are a resulting sintered ?lm thickness of from 0.4 mm. to 0.6
selected to be slightly smaller than the size of the ex 55 mm.
panded ?lm so that the rings can be installed while the The calendered ?lm is then ready for expansion. The
?lm is still grasped by ?lm gripping members 54-68. rectangular ?lm is initially trimmed to the shape of the
Accordingly, once the clamping rings are secured, as gripping members of the expansion apparatus. For ex
shown in FIG. 14, the portion of the ?lm outside of the ample, if the expansion apparatus of FIG. 1 is used, the
rings may be out free to allow the locked expanded ?lm 60 ?lm is trimmed to an octagonal shape using the template
to be placed in a sintering oven with other expanded 53 shown in FIG. 12. Template 53 is slightly larger in
?lm. As shown in FIG. 15, a suspension hook 144 can be size than the area surrounded by ?lm gripping members
secured around one of the fastening bolts 142 to suspend when the expansion arms are initially directed toward
he locked expanded ?lm from a rack in a sintering oven. the center of the apparatus. The peripheral edges of the
After the clamped ?lm is cut from the expansion appa 65 ?lm are then secured to the ?lm gripping members
ratus, the remaining peripheral portions of the expanded between upper clamp members 70 and lower clamp
?lm are released from the ?lm gripping members by members 72 (see FIG. 4). The expansion apparatus of
removing hex head screws 78 to release upper clamp FIG. 1 is then placed in the oven, ensuring that the
 5,321,109
11 12
splined end 130 of drive shaft 114 is coupled with recess by a similar machine using only four expansion arms
127 of power coupler shaft 126. The oven door is and four gripping members designated 166, 168, 170,
closed, and the temperature in the oven is raised to a and 172. FIG. 6 shows the ?lm of FIG. 5 following
temperature approximately in the range of 200-300 expansion using the 8-arm machine. The original grid is
degrees Centigrade before expanding the ?lm, and pref still recognizable and the lines of the grid are still rela
erably in the range of 225-275 degrees Centigrade. The tively straight, indicating relatively uniform expansion
expansion operation can be carried out at atmospheric in all directions. In contrast, FIG. 7B shows the ?lm of
pressure. ' FIG. 7A following expansion using the 4-arm machine.
The unexpanded ?lm is incubated in the oven for The grid of FIG. 7B is distorted, indicating that the
5-10 minutes after the oven temperature has stabilized expansion using the 4-arm machine was not as uniform
to ensure that the ?lm has come up to the desired teml‘ as the expansion using the 8-arm machine.
perature. After the incubation period has elapsed, a In addition, tests were performed on PTFE expanded
timer and a speed control (not shown) attached to ?lms stretched with the 4-arm and 8-arm machines.
motor 128 (see FIG. 3) are set to operate the motor to Such tests were conducted to determine the suture re
expand the ?lm. The timer and speed control are set to tention strength of the two expanded ?lms in three
fully expand the ?lm over a 15 to 30 second duration. different directions, a) the “M” direction corresponding
The PTFE ?lm is expanded to be approximately three to the longitudinal axis along which the ?lm was ini
to four times its original size. For example, an unex tially extruded; b) the “T” direction corresponding to
panded ?lm measuring approximately 2.5 inches square the transverse direction, i.e., perpendicular to the extru
might be expanded to a ?nished size of approximately 20 sion axis; and c) along an axis bisecting the “M” and
8.5 inches square. “T” directions. The tests were conducted by loading
The aforementioned steps for expanding the ?lm are strips of the expanded ?lm cut along the M, T and 45
collectively represented by box 158 in the ?owchart of degree directions into a testing instrument. The test
FIG. 10. The expansion operation does not signi?cantly conditions included a suture bite of 2 mm., a pull speed
' affect the thickness of the PTFE ?lm. As noted earlier, 25 of 5 inches/minute, and a suture hole using a 0.013 inch
the expansion apparatus tends to stretch the ?lm slowly needle. Peak force prior to tearing was noted. The re
at ?rst; as the expansion arms pivot further away from sults of such tests showed that the samples expanded
the center of the ?lm, the gripping members rotate using the 8-arm machine had more uniform suture re
through an arc, and the linear rate of travel away from tention strength when compared along the M, T, and 45
the center of the ?lm accelerates. Moreover, because degree directions, as contrasted with the samples pro
the gripping members are pivotally secured to the inner duced using the 4-arm machine. The suture retention
ends of the expansion arms, the pulling force exerted by strength (in Kg.) recorded for such samples is set forth
each ?lm gripping member is maintained radial relative below:
to the center of the ?lm. In addition, because the grip
ping members rotate through an arc, the radial direction 35
along which each gripping member exerts its pulling M direction T direction 45 Degrees
force is continuously rotated. MM
The next step in the process is to remove the expan Sample 1 1.435 +/~ .252 2.663 +/— .372 2.239 +/- .305
sion apparatus from the expansion oven and to clamp Sample 2 2.022 +/-— .650 3.036 +/— .347 2.620 +/- .374
the expanded ?lm prior to sintering. The procedure for Sample 3 1.946 +/— .484 2.816 +/— .387 2.213 +/— .197
locking the expansion arms to drive ring 82 using lock Eight Arm Machine
bars has already been described. The locked expansion Sample 1 2.139 +/— .44 1.913 +/— 2.142 +/— .211
.225
arms and drive ring 82 are released from the expansion Sample 2 1.726 +/— .314 2.254 +/— 1.837 +/— .285
apparatus, as represented by box 160 in FIG. 10; then, .333
clamp rings 134 and 136 are secured to opposing faces 45 Sample 3 1.798 +/— .414 2.430 +/— 1.946 +/— .375
of the expanded ?lm in the manner described above to .374
clamp the expanded ?lm, as denoted by box 162 in FIG.
10. The peripheral portion of the expanded ?lm is cut From the data set forth above, it will be noted that the
away from the outer portion of the clamp rings, and the ' suture retention strength for the samples expanded
expansion apparatus is reset to receive another ?lm to 50 using the 8-arm machine is much less dependent on
be expanded. After a number of clamped expanded orientation than in the case of the samples expanded
?lms have been produced, they are placed in a sintering using the 4-arm machine. It is theorized that the greater
oven and heated to a temperature above 350 degrees the number of expansion arms, the more uniform will be
Centigrade to sinter the PTFE ?lm, thereby perma the resulting ?lm.
nently locking the ?lm in its expanded state. Preferably, 55 Those skilled in the art will now appreciate that a
this sintering operation is performed at a temperature in simple and inexpensive apparatus has been described for
the range of 375-400 degrees Centigrade for 8-9 min stretching and expanding ?lms of PTFE and like poly
utes. The ?nal sintering step is represented by box 164 in mer ?lms in a multitude of directions outwardly from
the flowchart of FIG. 10. the center of he original ?lm to provide a multi-direc
While the apparatus of the present invention has been tional expansion of the ?lm. It will also be appreciated
described as having eight expansion arms and eight ?lm that the present invention provides an improved
gripping members, those skilled in the art will appreci method of uniformly expanding PTFE ?lms in a multi
ate that such apparatus can be made with a different tude of directions to provide a multi-directional expan
number of expansion arms and gripping members. For sion of the ?lm. The ?lm produced using such apparatus
example, FIG. 5 is a top view of a PTFE ?lm prior to 65 and method exhibits greater uniformity in characteris
expansion using an 8-arm expansion machine. The ?lm tics such as suture retention strength. While the present
has been marked with PTFE ink to show a grid prior to invention has been described with respect to preferred
expansion. FIG. 7A shows the same PTFE ?lm grasped embodiments thereof, such description is for illustrative
 5,321,109
13
purposes only, and is not to be construed as limiting the
scope of the invention. Various modi?cations and
changes may be made to the described embodiments by
those skilled in the art without departing from the true
spirit and scope of the invention as de?ned by the ap 5
pended claims. '
We claim:
1. A PTFE ?lm uniformly expanded in multiple di
rections, the PTFE ?lm having a center, the PTFE ?lm
being produced by the process comprising in combina
tion the steps of:
a. extruding a ?lm of PTFE:_
b. securing the periphery of the extruded PTFE ?lm
to a plurality of symmetrically-disposed ?lm grip
ping members, each of said ?lm gripping members 15
being equidistant from the center of the PTFE ?lm,
14
the plurality of ?lm gripping members exceeding
four in number;
. heating the extrude PTFE ?lm to a temperature in
the range of 200-300 degrees Centigrade before
expanding the extruded PTFE ?lm;
. simultaneously rotating each of the plurality of ?lm
gripping members through an are away from the
center of the PTFE ?lm to stretch and expand the
10 ?lm while maintaining the plurality of ?lm grip
ping members equidistant from the center of the
PTFE ?lm; and
. maintaining the pulling force exerted by each ?lm
gripping member radial relative to the center of the
PTFE ?lm.
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